(2) Drugs whose plasma concentration may be changed by the Product
① The Product showed competitive inhibitory effect against CYP3A4 in in vitro, but its IC50 (11.7 μM) was about 100 times higher than the maximum plasma concentration in the clinical dose (40㎎ basis).
② As a result of co-administration of three preparations, 80 mg of the Product, 1 g as amoxicillin and 500 mg as clarithromycin twice a day for 7 days to healthy adult males, the AUCT and Css,max of clarithromycin were decreased by 23% and 28%, respectively and the AUCT and Css,max of amoxicillin were decreased by 14% and 33%, respectively.
③ The Product showed competitive inhibitory effect against MATE1, MATE2K and OCT1 in in vitro, but it is unlikely to increase the blood concentration of the transporter substrate drug when considering the maximum plasma concentration at the clinical dose (40 mg basis).